BlackBox RPM

GUDID B963102C1

Cellular Blood Pressure monitor

Blackbox Remote Patient Monitoring LLC

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: B963102C1
• NIH Device Record Key: c334b63d-d28c-4ad2-b432-6ea9bc6d6df4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BlackBox RPM
• Version Model Number: BPM-102C
• Company DUNS: 117652799
• Company Name: Blackbox Remote Patient Monitoring LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B963102C1 [Primary]
HIBCC	B963BB10BPM102C10 [Package]; Package: Carton [10 Units]; In Commercial Distribution

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-09
• Device Publish Date: 2021-08-01

On-Brand Devices [BlackBox RPM]

• B963BPM201W1: Blood Pressure monitor designed to be used seamlessly with our proprietary hub or mobile app.
• BB4B963PO401W1: Pulse Oximeter
• B963102C1: Cellular Blood Pressure monitor